Achieve Life Sciences, Inc.

Greetings. Welcome to Achieve Light Science's third quarter earnings conference call and webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded. At this time, I'll turn the conference over to Nicole Jones with Investor Relations. Nicole, you may now begin.

Thank you, operator, and thank you to everyone for joining the call today. Today from Achieve, we have John Bensich, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, and Jerry Wan, Principal Accounting Officer. Achieve's management will be available for Q&A after the prepared remarks. I'd like to remind everyone that today's conference call contains forward-looking statements based on current expectations. These statements are only predictions, and actual results may vary materially from those projected. Please refer to achieved documents available on our website and filed with the SEC concerning factors that could affect the company. I'll now turn the call over to John.

Thank you, Nicole. And thanks, everyone, for joining us today to review our third quarter highlights and the overall status of the Cytosinicline program. Over the last quarter, as well as throughout the entire year, significant progress has been made in establishing the foundation for the first novel nicotine dependence treatment in almost two decades. So far this year, with a small and efficient team of only 22 full-time employees, Achieve accomplished many significant milestones, including the announcement of positive results from our second Phase III cytosinicline trial for smoking cessation, and published results from our first Phase III trial in JAMA. reported a statistically significant efficacy benefit in the Phase II ORCA V1 trial, the first ever randomized controlled trial for e-cigarette cessation. We've completed three additional clinical studies of over 100 subjects required for NDA submission, made significant progress on the compilation of the NDA, held numerous interactions, and conducted three formal meetings with the agency to prepare for filing and approval in the U.S. including most recently a pre-NDA discussion that occurred at the end of October, and increased outreach and further discussions with potential commercial organizations on the cytosine and clean U.S. and global marketing opportunity. We believe, pending FDA approval, cytosine and clean holds promise for providing a fresh start to the millions grappling with quitting smoking and vaping. There remain over 1 billion cigarette smokers around the globe. In the United States alone, over 28 million adults smoke combustible cigarettes and 11 million adults vape nicotine. The market potential for cytosinicline is substantial, and its potential impact on global public health is unparalleled. We have strong confidence in cytosinicline's effectiveness in assisting individuals who are motivated to quit smoking. Our Phase III clinical trial results demonstrate a significant advantage, with smokers treated with cytosinicline being up to eight times more likely to successfully quit smoking compared to those receiving placebo. Notably, cytosinicline stands out from existing treatments due to its excellent tolerability, with the most common adverse events affecting fewer than 10% of trial participants. We perceive a distinct opportunity with cytosinicline to reinvigorate the nicotine de-addiction market and make a profound impact on public health. By introducing this new treatment option, we anticipate a higher number of individuals will be encouraged to embark on a new quit attempt. With a product that is well tolerated, we anticipate a high level of compliance and adherence to treatment, thereby enhancing their chances of successfully quitting. Our confidence in cytosinicline is reinforced by leaders in the smoking cessation community who have consistently shown their willingness to collaborate, express interest in new research, and assist us in disseminating these crucial findings. During our engagements with this influential community, they have expressed that the goal for a new therapy should be to double the likelihood of a successful quit compared to behavioral support alone. Cytosinicline vastly exceeds this threshold. with subjects in our ORCA studies treated with cytosinicline having odds of quitting improved by upwards of six to eight times. This quarter, our research of the optimized dosing and administration of cytosinicline in U.S. subjects was published in the highly esteemed medical journal JAMA. This recognition has made a significant impact, garnering thousands of online views and being featured in more than 40 media outlets. Furthermore, during this quarter, Dr. Nancy Rigotti, an ORCA primary investigator and professor of medicine at Harvard Medical School and the director of the Tobacco Research and Treatment Center at Massachusetts General Hospital, presented, for the first time, data results from the Phase II ORCAv1 trial of cytosinicline for e-cigarette cessation at the Society for Research on Nicotine and Tobacco annual European meeting. ORCA-V1 evaluated the safety and efficacy of cytosinicline treatment for 12 weeks compared to placebo in 160 adults who used nicotine e-cigarettes. Cytosinicline-treated subjects experienced statistically significant cessation rate of approximately 32% compared to 15% in the placebo arm, or 2.6 times higher odds of quitting vaping. As seen across our development program, cytosinicline was very well tolerated and no treatment-related serious adverse events were reported. Our endeavors to combat the vaping epidemic have been met with strong support from government agencies, clinicians, and prospective commercial partners, highlighting the pressing unmet need in this area. ORCAv1 was the first randomized placebo-controlled trial to achieve success in demonstrating the efficacy of a treatment for addressing this type of nicotine dependence. These results are highlighted as there are currently no approved treatments tailored specifically for vaping cessation. The overall e-cigarette market continues to expand rapidly, with the most recent prevalence rate in the U.S. indicating a 20% annual increase of adult users. While e-cigarettes can serve as a helpful tool for some transitioning away from combustible cigarettes, the long-term effects remain unknown, and many individuals aspire to quit nicotine altogether, which is precisely where cytosinicline can step in. We are assessing our clinical development strategy to pursue an on-label indication for e-cigarette cessation and plan on holding an end-of-Phase II meeting with FDA in 2024 to discuss the requirements for approval. As there are no treatments approved for e-cigarette cessation, this is a recognized area of high unmet need, and we will position it as such during our discussions with the FDA. Our goal is to expand the label of cytosinicline for specific promotions for e-cigarette cessation, even though many healthcare providers may consider cytosinicline a viable option for treating various forms of nicotine dependence. As you may recall, ORCAv1 was partially financed via non-dilutive grant funding from NIDA and NIH. We believe there may also be non-dilutive funding opportunities available to support a future basing study. Our aspirations of changing public health hinge on the regulatory filing and successful approval of cytosinicline. To that end, we have been focused on continuing the work needed to support an NDA filing, targeted in the first half of 2024. We are pleased to share that we have completed all of the in-clinic treatment portions of three NDA-enabling clinical trials that have been running over the course of this year. Specifically, these trials have been run to evaluate QT interval prolongation, steady state pharmacokinetics in smokers, and pharmacokinetic parameters in subjects with renal impairment. We expect final study reports from these trials to be available in early 2024. Additionally, last week we held a pre-NDA meeting with the FDA. The FDA encourages this pre-submission engagement to solicit comments and clarification from the agency on the acceptability of key data, including information that might become available for submission during NDA review. This initial discussion was constructive, and agreement was reached on many of the submission requirements. Dialogue with the FDA is ongoing, and because of this, we aren't able to provide additional details at this time. We will be in a position to provide an overview once discussions are finalized. The output of the pre-NDA discussion is critical to clarifying the final regulatory path of cytosinicline in the US, and will set the stage for how this product will progress through future market approvals around the globe. Additionally, these data points are important to furthering the discussions we are having with potential commercial organizations. Since ORCA V1 and ORCA 3 have been released and ORCA 2 was published in JAMA, we have seen significant additional commercial interest in the Cytosinicline program. As we have stated previously, we continue to believe that this asset in the hands of a larger organization will maximize the full commercial opportunity. What are we looking for exactly? Our ideal partner would have global capabilities with an established footprint and strong commercial capabilities and resources to maximize the global health impact that Cytosynaclean offers. Given the substantial U.S. market opportunity, strong U.S. sales and marketing capabilities are an important attribute that we are seeking in our selection process. We are pleased with the dialogue and engagement with potential commercialization partners and are focused on continuing to move this process forward expeditiously. At this time, I'll hand the call over to Jerry to review our financial highlights and results.